• Berlin Heart (Berlin, Germany) said that its Excor pediatric ventricular assist device (VAD) has received unconditional approval for the ongoing IDE clinical trial in the U.S. The Excor is a mechanical cardiac support system for critically ill pediatric patients suffering from severe heart failure. Unlike standard heart-lung machines, Excor Pediatric has been used as a short-term, mid-term and long-term support system, supporting failing hearts from days up to several months. The system is designed to bridge patients awaiting heart transplantation until a donor heart becomes available, but also has been used successfully as a bridge to recovery when a patient's heart was able to recover and work on its own again.

• GE Global Research (Niskayuna, New York), the technology development arm of General Electric, reported a battery-free, multi-detection radio frequency identification (RFID) sensing platform that could enable a wide range of low cost wireless sensing products in healthcare, security, food packaging, water treatment and pollution prevention. GE's RFID sensors are built on traditional RFID tags. This "first-of-its-kind" sensing platform, in which a single sensor can provide a highly selective response to multiple chemicals under variable conditions, operates without a battery. GE's sensor technology overcomes limitations in today's sensors such as inadequate response selectivity and the need for an on-board power source.

• iCAD (Nashua, New Hampshire) reported introduction of two MRI products. The SpectraLook is a kinetics technology integrated into iCAD's image analysis solutions for breast and prostate MRI studies; and CADvue is an image review and analysis software designed to improve the analysis workflow, interventional planning and reporting of breast MR results. SpectraLook, iCAD's breast MR analysis solution, provides more diagnostic information by creating colorized images based on signal changes defined by tumor physiology. CADvue image review and analysis software provides maximum functionality facilitating the analysis of ATP colorized images and quantitative data. CADvue allows the user to create standard and customized reports that enable the user to communicate time-sensitive breast MR study results to referring physicians.

• Pioneer Surgical Technology (Marquette, Michigan) reported the U.S. market release of its FortrOss bone graft substitute. The FortrOss bone void filler, utilizing the power of nanotechnology for orthopaedic applications, is a scaffold for the in-growth of new bone when superior bone regeneration is required. The FortrOss bone void filler combines the nanotechnology of nanOss hydroxyapatite with the bone growth promotion of E-Matrix scaffold. The FortrOss bone void filler is the most advanced on the market. The FortrOss osteoconductive matrix utilizes Pioneer's nanOss technology and is designed to mimic the nanostructures inherent in bone tissue.

• RF Surgical (Bellevue, Washington) has received FDA approval to market its Blair-Port Wand as a reusable scanning devise with a 24-hour activation lifecycle in the OR. Prior to beginning closing procedures, a surgical patient is scanned with the wand. If any RFDetect tagged surgical sponges, gauze or towels remain in the patient, a signal will alert the surgical team and allow them to remove the retained sponge. Retained surgical sponges are one of the leading patient safety concerns in hospitals—occurring at an estimated rate of 1 in every 1,000 to 1,500 intra-abdominal surgeries.

• Smart Disc (Allen Park, Michigan) reported that it has conducted a cadaver test using its artificial spinal disc technology and that the test was deemed a success by the surgeons involved. The Smart Disc prosthesis is intended to maintain the normal movement between the vertebral bodies and prevent them from collapsing and thereby irritating or damaging the nerve root by maintaining the disc space height between the bones.

• VertiFlex (San Clemente, California) reported the launch of Silverbolt Plus, a posterior fixation system designed to support all types of surgical approaches in the lumbar spine – percutaneous, mini-open and open — in one single instrument set. "Silverbolt Plus is the first system to give surgeons a complete solution for posterior lumbar fixation. With this single instrument set, a surgeon has access to a variety of instrumentation options — percutaneous delivery of single and multiple vertebral levels, percutaneous dynamic stabilization with our Dynabolt Dynamic Rod, and supplemental instruments for mini-open and open approaches," said President/CEO Earl Fender.

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